CDC und FDA ignorieren weiterhin das Schlaganfallrisiko und vermeiden es, sich damit auseinanderzusetzen

Thrombotic-embolic events are among the most common and dangerous risks of COVID-19 vaccines. This includes strokes, which almost always lead to severe disabilities. The bivalent mRNA boosters appear to be even more dangerous in this regard. However, the US CDC and FDA are trying to downplay this problem with tricky studies and pass the blame onto simultaneous flu vaccinations. In mid-October, a preprint article (Lu et al. 2023) from the FDA’s circle appeared, which focused on strokes as a side effect of the first bivalent generation of COVID-19 vaccines. The article wanted to suggest that these vaccines were not problematic in terms of strokes, unlike simultaneous influenza vaccinations. However, the methodology raises many questions. It was also remarkable that the authors largely avoided the question of why they considered an analysis of strokes to be important. They apparently wanted to avoid quantifying and proving the problem in any way. What must the CDC and FDA have known? The US Centers for Disease Control and Prevention (CDC) was legally forced to disclose its signal detection analyses, also known as disproportionality analyses (DPA), for COVID-19 vaccines in mid-2022. It was not until the end of 2022 that they fulfilled this obligation; I reported on it here in February 2023. In addition to some deficiencies in the CDC’s analyses, I also showed that the circle of embolic, hemorrhagic, or thrombotic (E/H/T) events showed the clearest signals; so clear that there was no longer any need to debate causality. Could the CDC and FDA have overlooked this? On April 19, 2023, Tom Shimabukuro from the CDC gave a presentation to the FDA on this topic or the then bivalent vaccines. He vaguely mentioned at the beginning that the CDC had seen a signal regarding strokes with bivalent Comirnaty and people over 65 years old; not a word, at least not publicly, about the problematic original products! By then, about 1.8% of people over 65 had received a bivalent booster (Fig. 1); one would have expected higher numbers for a blockbuster. Apparently, vaccine fatigue has even spread in the USA. Fig. 1 Vaccinated doses administered since approval of the bivalent products, age >65 From Tom Shimabukuro’s presentation to the FDA. Approval of the mRNA on August 31, 2022, data until April 12, 2023. In his presentation, Shimabukuro only wanted to consider a weak signal at the end of the observation period; he did not want to recognize around 10 signals during most vaccinations as such (Fig. 2). Fig. 2 CDC’s signal detection for strokes, age >65 Marked by the author. However, all red circles also indicate a signal. From Tom Shimabukuro’s presentation to the FDA. See Fig. 1. Shimabukuro obviously followed the motto: Move along, there’s nothing to see here. At least almost nothing. Because he somehow felt compelled to pass the blame onto influenza vaccinations. Since I was surprised by this exoneration of the mRNA vaccines and the suspicion of the flu vaccines, I first conducted DPA on current and past data, with alarming results (Fig. 3). The proportional rate ratios (PRR) for Comirnaty are all close to 10, with small confidence intervals. So these are undoubtedly vaccine reactions. The estimates for the bivalent product are consistently higher, so the bivalent product is also significantly higher and therefore riskier in direct comparison. This is obvious because the dose was almost twice as high. Fig. 3 DPA from US-VAERS data for strokes, age >65 PRR = proportional rate ratio = rate of ratios. The error bars show 95% confidence intervals. Control: Any case related to a vaccine (except „unknown“ and COVID-19 vaccines (due to data errors) that occurred between 2012 and November 2020. Comirnaty*: Original Pfizer-BioNTech COVID-19 vaccine, suspected case reported, vaccinated and start until August 31, 2022 (FDA approval of the bivalent product). Com. bivalent: Any suspected case related to the bivalent Pfizer-BioNTech product until October 23, 2023. TIA: Transient ischemic attack, also known as a mini-stroke. For details, see the appendix. Strokes are clearly vaccine reactions to mRNA vaccines. The bivalent products showed even higher incidences than the original products. To date, neither stroke nor similar terms explicitly appear in European or American product information. Due to the above-mentioned DPA by the CDC, it must be assumed that the CDC and FDA were aware of these enormous risks no later than the summer of 2022, but probably much earlier. Therefore, there is a suspicion that these authorities have massively distorted their recent analyses to divert attention from these risks. How were the analyses distorted? Currently, there are three analyses on this topic. In addition to the already mentioned ones by Lu et al. 2023 and Tom Shimabukuro, there is also one by Gorenfloh et al. (preprint, 2023). The latter can be quickly dismissed: although this work has been available on the medRxiv server since mid-February 2023, no one has paid attention to it yet. In fact, it is contradictory, so it remains unclear what the authors actually compared. The estimates are not comprehensible. All three studies have in common that they primarily compared the bivalent products from Pfizer and Moderna against each other. Of course, you can only detect a safety signal if one product should be significantly worse. The relative risk compared to other vaccines or even the absolute risk will at best be recognized as an incidental finding. Furthermore, these studies have in common that they represent a self-controlled case series (SCCS) study. In SCCS studies, one should ideally compare a pre-exposure phase, i.e., before vaccination, with a post-exposure phase. All of these studies (unclear in Gorenfloh et al.) only compared post-exposure phases with each other, which is not sensitive. Another, albeit possibly small problem with SCCS is that such designs cannot work for death as an endpoint because there is no second phase for such cases. This also means that a bias is introduced for fatal cases

Original Artikel Teaser

CDC und FDA reiten immer weiter ins Abseits: Beim Schlaganfallrisiko schauen sie angestrengt weg

Thrombotisch-embolische Ereignisse gehören zu den häufigsten und gefährlichsten Risiken der COVID-19-Impfstoffe. Darunter fallen auch Schlaganfälle, die fast immer zu schweren Behinderungen führen. Die bivalenten modRNA-Booster scheinen in dieser Hinsicht sogar noch gefährlicher zu sein. Dennoch versuchen US-CDC und FDA mit trickreichen Studien dieses Problem zu negieren und den schwarzen Peter an gleichzeitige Grippeimpfungen weiterzureichen. Mitte Oktober erschien ein Preprint-Artikel (Lu et al. 2023) aus dem Dunstkreis der FDA, der sich dem Thema Schlaganfälle (Engl.: stroke) als Nebenwirkung der ersten bivalenten Generation der C19-Impfstoffe widmete. Der Artikel wollte vor allem suggerieren, dass diese in Sachen Schlaganfälle unproblematisch seien, im Gegensatz zu gleichzeitig verabreichten Influenza-Impfungen. Die Methodologie wirft aber viele Fragezeichen auf. Bemerkenswert war auch, dass die Autoren weitgehend die Frage umschifften

Details zu CDC und FDA reiten immer weiter ins Abseits: Beim Schlaganfallrisiko schauen sie angestrengt weg